JP2022506208A - Systems and methods for measuring bioimpedance body composition - Google Patents

Abstract

A system for measuring the body composition of at least one body segment of a patient. Multiple contact components, including multiple electrodes that come into contact with the patient's body, each contact component associated with a unique address, and each contact component at intervals in different locations on the patient's body. Multiple contact components and at least one multimedia bus bar that can be placed independently of each other, each multimedia bus bar being connected to the electrodes of at least two contact components. And an impedance that indicates the impedance of the first body segment located between the first set, selecting the first set of contact components connected by a common multimedia bus bar using a unique address. A system is provided that comprises a controller that obtains measurements and provides impedance measurements for estimating body composition of the first body segment.

Description

[Related application]
This application claims the priority benefit of US Provisional Patent Application No. 62 / 755,650 filed on November 5, 2018, the contents of which are incorporated herein by reference in their entirety. ..

[background]
The present invention relates, in some embodiments thereof, to body composition measurement, and more specifically, but not exclusively, to systems and methods of body composition measurement using impedance measurement.

Body composition measurement is, for example, a valuable tool for assessing nutritional status and physical fitness in various clinical settings.

As a method for evaluating the body composition in a living body, a double energy X-ray absorption method (DXA), a computed tomography method (CT), a magnetic resonance imaging method (MRI) and the like are often used. Although these diagnostic imaging methods can accurately measure body composition, they are expensive, take a long time to measure (acquisition of MRI images, etc.), and are exposed to radiation in CT and / or DXA. Their practical use (for routine measurements, for example) is limited. Therefore, low-cost, high-speed, and bioelectrical impedance measurement that does not irradiate patients is increasingly being introduced for patient monitoring, nutritional management, and management of patient muscle mass and hydration status in the ICU.

According to a first aspect, a system for measuring body composition in at least one body segment of a patient, comprising: Multiple contact components containing multiple electrodes for contact with the patient's body, each contact component associated with a unique address, and the multiple contact components at different locations on the patient's body. Multiple contact components that can be placed independently at intervals, and at least one multimedia bus bar, each of which is connected to the electrodes of at least two contact components, at least one. Select the first set of contact components connected by a common multimedia bus bar using one multimedia bus bar and their unique address, located between the first set of contact components. It comprises a controller that obtains at least one impedance measurement indicating the impedance of the first body segment and provides at least one impedance measurement for estimating the body composition of the first body segment.

According to the second aspect, the method of measuring body composition in at least one body segment of a patient comprises a first set of contact components among a plurality of contact components connected by a common multimedia bus bar. , A step of election, each contact configuration, by sending an instruction indicating a unique address and assigning it as the current and / or detection element of the first set of corresponding contact components on a common multimedia bus bar. The elements include multiple electrodes for contact with the patient's body, each contact component is associated with its own unique address, and the multiple contact components are spaced apart from each other at different locations on the patient's body. The step of selecting, which can be arranged independently, and the step of acquiring at least one impedance measurement value using the first set of electrodes of the contact component, the at least one impedance measurement value is a contact configuration. A step of obtaining an indication of the impedance of a first body segment located between a first set of elements and a step of providing at least one impedance measurement for estimating the body composition of the first body segment. Be prepared.

In a further embodiment of the first and second embodiments, the addressing instruction output by the controller defines the operation of the corresponding electrode as a current carrier or voltage sensor and / or assigns an operation type of the component.

In a further embodiment of the first and second embodiments, the estimation of body composition comprises an estimation of muscle mass.

In a further embodiment of the first and second embodiments, each contact component of the plurality of contact components comprises three electrodes arranged along the major axis of each contact component, the controller. The intermediate electrodes of each contact component of the first set of contact components are operated for current transmission, and the inner counter electrodes of each contact component of the first set are operated for voltage measurement.

In a further embodiment of the first and second embodiments, the plurality of contact components and the multimedia bus bar are integrated into a single flexible strip in which the address incorporates the assignment.

In a further embodiment of the first and second embodiments, a single main multimedia bus bar connects the controller to each one of the plurality of contact components.

In a further embodiment of the first and second embodiments, each of the plurality of electrodes is associated with each electrode component having its own unique address, and the controller addresses each electrode component. Selects a set of electrodes for each of the different contact components.

In a further embodiment of the first and second embodiments, at least some electrodes are attached to a sleeve designed to be worn on a part of the body, the sleeve being designed to inflate. Having a double wall with a lumen, the sleeve is connected to the controller via a multimedia bus bar to induce substantially equal contact pressure between the electrodes and parts of the body when in use. A 3D map is formed by inflating the sleeve and collecting data from multiple detection strips and / or sensors embedded in the sleeve worn on a part of the body.

In a further embodiment of the first and second embodiments, the multi-electrode strip is attached to a part of the body by an adhesive and its output for 3D impedance mapping and / or modeling is the muscle of the part of the body. Indicates the amount.

In a further embodiment of the first and second embodiments, the controller repeatedly selects a second set of contact components among a plurality of contact components connected by a common multimedia bus bar, and of the contact components. By measuring the impedance using a second set of electrodes, at least one impedance measurement is collected, and the at least one impedance measurement is located between the second set of contact components. Shows the impedance of the body segment of the second body segment and provides at least one impedance measurement for estimating body composition including muscle mass and / or fat-free mass of the second body segment.

In a further embodiment of the first and second aspects, at least one contact component of the first set of contact components is placed between the second set of contact components and the first set of contact components. A pair and a second set of contact components are connected to a common multimedia bus bar.

In a further embodiment of the first and second embodiments, at least one contact component of the first set of contact components is placed between the second set of contact components and a second set of contact components. During at least one impedance measurement performed for each body segment placed between the pairs, the corresponding electrodes are not selected and activated.

In a further embodiment of the first and second embodiments, one of the second set of contact components is selected from the first set of contact components.

In a further embodiment of the first and second embodiments, a plurality of biosensors, each associated with a unique address, are further comprising the plurality of biosensors in at least one multimedia bus bar connected to the plurality of electrodes. Connected, the controller operates multiple biosensors and multiple electrodes by transmitting a particular unique address on at least one multimedia bus bar.

In a further embodiment of the first and second embodiments, the plurality of biosensors is selected from the group consisting of pressure sensors, temperature sensors, pulse sensors, sound sensors, and skin conductance sensors.

In a further embodiment of the first and second embodiments, each contact component of the first set and the second set of contact components comprises three electrodes arranged along a major axis, the controller. Current is injected and received using the intermediate electrodes of each of the first and second sets of contact components, and the controller is inside the first and second sets of contact components. Measure the voltage using the counter electrode.

In a further embodiment of the first and second embodiments, the body tube is further provided for insertion into the lumen of the patient's body, the body tube comprising a plurality of electrodes for contacting the inner surface of the patient's body, respectively. , Combined to at least one contact component associated with each unique address. At least one multimedia bus bar is connected to at least one contact component of the body tube and at least one contact component located outside the patient's body, the first set of contact components being the body tube. At least some of the electrodes are individually directly connected to the controller without an addressing scheme, including at least one contact component of the patient and one contact component located outside the patient's body. ..

In a further embodiment of the first and second embodiments, the body tube is selected from the group consisting of an endotracheal tube (ETT), a feeding tube, and a nasogastric tube (NG).

In a further embodiment of the first and second embodiments, the at least one impedance measurement performed by the first set of electrodes of the contact component indicates the body composition of at least one lung.

In a further embodiment of the first and second embodiments, the controller iteratively switches between the first and second sets of contact components, the first plurality over a time interval for the first body segment. Monitor impedance measurements and monitor a second plurality of impedance measurements over a time interval for the second body segment.

In a further embodiment of the first and second embodiments, the body composition of the first and second body segments is captured in a graphical user interface (GUI) based on real-time first and second plurality of impedance measurements. It is characterized by further providing a processor that executes the code to be displayed in and dynamically updated.

In a further embodiment of the first and second embodiments, the processor corresponds to a body map depicting the location of the first and second body segments, with FFM, muscle mass and FFM of the first and second body segments. / Or execute the code to display the body composition including the hydration status.

In a further embodiment of the first and second embodiments, the GUI displays the body composition of the first and second body segments as indicators along a range of different body compositions.

In a further embodiment of the first and second embodiments, when a plurality of impedance measurements of the first and second are analyzed and body composition such as at least one 14 of the first and second body segments is clinical. It further includes predicting whether a critical goal will be reached and generating warnings to indicate the prediction.

In a further embodiment of the first and second embodiments, compound correlation is performed via an artificial intelligence (AI) model that combines food intake and muscle mass loss, stored in memory and obtained from a body part sensor. Further included code that can be performed to form the analysis, the analysis results are to optimally manage the patient's feeding pump / nutritional components to maintain or restore muscle mass and / or desired hydration status. used.

In a further embodiment of the first and second embodiments, the clinically significant goal is selected from the group consisting of dehydration, hypervolemia, and FFM.

In a further embodiment of the first and second embodiments, the body composition is selected from the group consisting of fat content, edema, water content, electrolyte content, and pathological condition.

In a further embodiment of the first and second embodiments, for each of the first and second sets of contact components, the controller measures impedance at a plurality of different frequencies and by a plurality of different frequencies and sensors. It further comprises a processor running code to generate and display 3D maps for the first and second body segments using linear gradient measurements based on the collected data.

In a further embodiment of the first and second embodiments, the output is obtained from at least one other biosensor connected to the connected multimedia bus bar, and the impedance measurement is output from at least one other biosensor. Further includes displaying in combination with.

In a further embodiment of the first and second embodiments, the collected data allows 3D modeling of the inspected body part.

Further embodiments of the first and second embodiments further include providing a GUI incorporating patient condition information including estimation of body composition.

In a further embodiment of the first and second embodiments, the estimation of body composition comprises muscle mass and / or hydration status.

In a further embodiment of the first and second embodiments, the estimation of body composition comprises the amount of change in muscle per body segment, and the controller controls the change in muscle mass and lipids, carbohydrates, proteins for administration to the patient. Based on the correlation data set correlated with and / or the amount of fat, the amount of lipids, carbohydrates, proteins, and / or fat for each body segment was calculated and for each of the multiple body segments. According to the aggregation of the amount of lipids, carbohydrates, proteins, and / or fats, the feeding pump generates instructions for feeding the patient.

Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by ordinary technicians in the art to which the invention relates. have. Methods and materials similar to or equivalent to those described herein can be used in the practice or testing of the invention, but exemplary methods and / or materials are described below. In the event of inconsistency, the patent specification containing the definition will prevail. Also, the materials, methods, and examples are merely exemplary and are not intended to be limited.

Some embodiments of the invention are illustrated only by way of reference with reference to the accompanying drawings. With reference to the drawings in detail here, it is emphasized that the particulars presented are exemplary and are intended to illustrate embodiments of the invention. In this regard, the illustrations will make clear to those skilled in the art how embodiments of the present invention may be practiced.

FIG. 1 shows one or more of patients by selectively operating the electrodes of a contact component among a plurality of contact components connected by a multimedia bus bar according to some embodiments of the present invention. It is a schematic diagram of the system for measuring the body composition of the body part of. FIG. 2 shows a computer-implemented method for selectively activating the electrodes of a contact component among a plurality of contact components connected by a bus bar according to some embodiments of the present invention. It is a flowchart. FIG. 3 is a schematic diagram illustrating an exemplary architecture of addressable electrode components according to some embodiments of the invention. FIG. 4 is a schematic implementation of an exemplary implementation of two contact components coupled to the same multimedia bus bar, according to some embodiments of the invention. FIG. 5 illustrates an independently addressable, arranged contact component on a common multimedia bus bar to monitor multiple body segments of a patient, based on some embodiments of the invention. It is a figure. FIG. 6 includes an additional contact component with electrodes arranged to measure impedance for estimating cardiac output, according to some embodiments of the invention, with reference to FIG. It is a schematic diagram based on the setup described above. FIG. 7 shows additional contacts placed on the left side of the patient's body in addition to the contact components placed on the right side of the patient's body as in FIGS. 5 and 6, according to some embodiments of the invention. FIG. 6 is a schematic based on the setup described with reference to FIG. 6 (and FIG. 5), including contact components. FIG. 8 is a schematic diagram of an architecture in which each contact component is connected to a main multimedia busbar via individual cables, according to some embodiments of the invention. FIG. 9 is a schematic diagram of an architecture in which each electrode is connected to a main multimedia busbar via a separate cable, according to some embodiments of the invention. FIG. 10 is a schematic showing exemplary contact components brought into contact with a patient's skin to measure the impedance of a body segment containing tissue, according to some embodiments of the invention. FIG. 11 is a schematic diagram showing examples of whole body segment measurements and leg segment measurements to aid in understanding some embodiments of the invention. FIG. 12 includes a piccoli diagram of a whole body and a part of the body to help understand that the accuracy of the impedance measured in the whole body is improved compared to the whole body. FIG. 13 is a schematic diagram showing the process of selective activation of electrodes of a plurality of contact components for sensing a plurality of body segments according to some embodiments of the present invention. FIG. 14 includes some exemplary BIS equations according to some embodiments of the invention. FIG. 15 includes some exemplary equations for calculating exemplary health parameters according to some embodiments of the invention. FIG. 16 is a schematic representation showing an exemplary representation based on analyzed impedance measurements of body segments according to some embodiments of the invention. FIG. 17 is a schematic representation of an exemplary representation of impedance data for a plurality of body segments according to some embodiments of the invention. FIG. 18 is a schematic cross-section of a patient's foot wearing an inflatable sleeve with electrodes and a schematic cross-section of the foot with electrodes on a conductor strip, according to some embodiments of the invention. include.

The present invention relates, in some embodiments thereof, to body composition measurement, and more specifically, but not exclusively, to systems and methods of body composition measurement using impedance measurement.

One embodiment of some embodiments of the invention is a system, method, device, and / or (eg, stored in memory and hardware) for obtaining impedance measurements of one or more body segments of a patient. With respect to code instructions (which can be executed by the hardware processor), clinical studies have shown that, for example, impedance data of the patient's body parts and other sensor data form clear indicators of muscle mass and hydration status, respectively. A system, method, device, and / or code instruction (eg, stored in memory and runn by a hardware processor) for estimating and / or measuring and / or bedside monitoring the body composition of a body segment. It is about.

The information provides closed-loop control of the nutritional intake assigned to the treated patient, resulting in optimal recovery. The patient may be diagnosed, treatment planned, and / or the patient may be treated based on body composition. Contact components are provided. The contact component is designed to be placed on the patient's skin at the discretion of the patient and includes multiple electrodes for contact with the patient's body. The contact components are separate structures that are not necessarily connected to each other, apart from the multimedia bus bar that connects the two or more contact components to the controller. Each contact component can be independently placed in different positions on the patient's body. The busbars are flexible and designed to give each contact component freedom of movement, so that the contact components can be spaced apart to monitor different body segments. Each contact component and / or each electrode of each contact component is associated with a unique address. The controller commands the operation of electrodes (eg, as a current injector, current receiver, anode, cathode, and / or voltage sensor) on a busbar connected to multiple contact components (at least two). Is issued via each unique address of each contact component and / or bus bar (eg, via an address decoder circuit). The controller uses each unique address to issue instructions to operate a selected set of contact components connected by a common multimedia bus bar, between a set of contact components. Obtain one or more impedance measurements that indicate the impedance of the body segment in which it is located and provide the impedance measurements for estimating the body composition of the body segment. The controller can sequentially and / or iteratively activate different sets of contact components for current injection and impedance measurements for different body segments, for example for real-time monitoring. In this method, two current injection electrodes can be provided on the body part to be inspected, and two voltage detection electrodes can be provided between them, which is a desirable four-electrode method for impedance detection.

Optionally, each contact component comprises three electrodes arranged along the long axis of each contact component. The controller operates each intermediate electrode of the set of contact components to inject current and operates each inner facing electrode of the set of contact components for voltage measurement.

As used herein, the inner facing electrode refers to the electrode of the set of contact components that is closest to each other. For example, in the case of a set of contact components located on the ankle and chest, the medial facing electrode of the ankle contact component is the closest electrode to the chest and the medial facing electrode of the chest contact component is on the ankle. The closest electrode.

At least some implementations of the systems, methods, devices, and / or code instructions described herein relate to the technical problem of reducing the number of cables and / or conductors for measuring the impedance of different body segments. It is a thing. At least some implementations of the systems, methods, devices, and / or code instructions described herein include a contact component architecture with three electrodes arranged along the long axis of the contact component. This technical problem is addressed by a controller that operates the intermediate electrode as a current injector and / or a current collector and the inner facing electrode as a voltage sensor. A contact component may be used to measure the impedance of two adjacent segments, eg, for a contact component placed on the trunk, an intermediate electrode is operated for current and a leg. The electrode at the end facing the head is operated for voltage detection of the leg, and the electrode at the other end facing the head is operated for voltage detection of the upper body.

The structure of the contact component (including the placement of the triad electrode along the line for applying a current and measuring the voltage of the applied current) is a body located in one direction of the contact component by a small number of conductors. It makes it possible to monitor the impedance of a segment and other body segments located in opposite directions of the same contact component. For example, for a contact component placed on the buttocks, for the body segment from the buttocks to the ankles and the other body segments from the buttocks to the head, a set of cables of their own using standard processes. Instead of four independent electrodes, each connected to, three electrodes of contact components connected to a common busbar can be used.

The architecture described herein makes it possible to place contact components (ie, electrodes on them) anywhere on the patient's body. A small number of conductors on the busbar (eg, one, two, or more) connect multiple contact components and monitor body segments between any set of contact components selected by addressing. It enables and therefore does not require a separate conductor for each sensor or electrode.

At least some implementations of the systems, methods, devices, and / or code instructions described herein relate to the technical problem of improving the measurement of impedance of a patient's body segment. At least some implementations of the systems, methods, devices, and / or code instructions described herein include a contact component architecture with three electrodes arranged along the long axis of the contact component. This technical problem is addressed by a controller that operates the intermediate electrode as a current injector and / or a current collector and the inner facing electrode as a voltage sensor. Since the current passes between the intermediate electrodes of the set of contact components, the voltage measured at the inner electrode of the set of contact components passes through the inner electrode on the way to the intermediate electrode, or is intermediate. The voltage drop generated by the current itself as it exits the electrode can be measured more accurately.

At least some implementations of the systems, methods, devices, and / or code instructions described herein relate to the technical problem of improving the accuracy of bioelectrical impedance measurements of a patient's body parts. It is intended to monitor patients at risk of internal bleeding and / or edema, for example, patients in an intensive care unit (ICU). Such patients may use bioelectrical impedance measurements, which are rapidly becoming popular as indicators of health, to, for example, detect current body composition or improve body composition trends (eg, worsening or improving). It can be monitored by monitoring (is it) or predicting future body composition. The three elements include a decoder, a switch electrode, and an amplifier, the last one being activated when a particular electrode is assigned as a voltage detection electrode. The addition of an amplifier makes it possible to use lower injection currents that are clinically always desired without sacrificing S / N.

Bioelectrical impedance analysis for measuring body composition (eg, in an ICU) may be performed using bioelectrical impedance vector analysis (BIVA). For example, by repeating hydration measurements with BIVA, more than 2 liters of water accumulation or water balance in ICU patients can be detected. A decrease in fat-free mass (eg, in a patient in the ICU) is associated with a worsening prognosis in patients with chronic disease. The association between fat-free mass upon admission to the intensive care unit and mortality after 28 days is an indicator. Fluid changes are known to be drastic in the intensive care unit, and the phase angle may predict mortality after 28 days. The sensor data collected has shown that the patient's nutritional intake can be optimally controlled in a closed loop, resulting in faster patient recovery.

At least some implementations of the systems, methods, devices, and / or code instructions described herein improve the technique of bioelectrical impedance analysis for measuring the body composition of a patient's body part. .. This improvement is addressed, at least in part, by selecting specific electrodes on the corresponding contact components (which may include three electrodes spaced along the long axis). It results from providing a measurement of the impedance of the body part. The electrodes can be selected according to their respective addresses. A relatively small number of conductors may be used if the segment of each body part is selected by addressable electrodes. As an alternative multimedia cable, conductors (metal layers or carbon-based layers such as graphene) may be mounted or vapor-deposited on strips of flexible printed circuit boards such as Kapton (DuPont). Existing systems and methods, on the other hand, use one conductor for each electrode (for point measurements at specific locations), but this complicates wiring and requires a large number of conductors, resulting in a small number. It is not practical to measure the impedance beyond the location of, and the interference caused by the large number of conductors causes interference between the signals.

Fat-free (FFM) contains almost all water and conductive electrolytes in the body, and while FFM hydration is constant, the basic premise of other systems and methods is the body (ie, ie). , Extremities and trunk) are regarded as a single conductive cylinder, and the relationship between the main cross-sectional areas does not change. This premise is meaningless, for example, in the case of the elderly, as the diameter of the conductive volume (cylinder) of the limbs becomes narrower due to the decrease in FFM with aging and the redistribution of adipose tissue from the limbs to the trunk. .. Each cylinder (ie, body part, by at least some implementation of the systems, methods, devices, and / or code instructions described herein to achieve improved accuracy and sensitivity of bioimpedance body composition measurements. For example, the limbs and / or the trunk) are measured independently (eg, segmental measurements). The reconstruction of the body segment may include other colors such as blue for higher water levels and red for the dehydrated body section for easier GUI color coding.

At least some implementations of the systems, methods, devices, and / or code instructions described herein improve the process of treating a patient based on bioelectrical impedance measurements. The water and / or electrolyte content of body tissue is clinically important in planning patient care and / or patient treatment. They indicate, for example, indicators of dehydration, fat content, edema, and other pathological conditions. Fat, cell boundaries, and water electrolytes directly affect the electrical impedance of the tissue being examined. Therefore, the measurement of conductivity is becoming more and more important as an index showing the health condition of patients. The improvement is that at least a relatively small number of conductors can be used to monitor multiple different physical parameters of the patient. The monitored data may be displayed in the GUI, analyzed and warned, and / or used for predicting the patient's future clinical status and controlling the patient's nutritional status in a closed loop. ..

であるから、インピーダンス

の小さな変化を検出することが遥かに容易になることに留意されたい。 At least some implementations of the systems, methods, devices, and / or code instructions described herein can improve the technique of performing impedance measurements using a segmented approach. The segment approach may be said to be each impedance measurement performed on a body part such as a leg having a specific impedance (denoted by z) instead of the impedance of the whole body (denoted by Z). With the segment approach,

Therefore, impedance

Note that it is much easier to detect small changes in.

The standard method requires a large number of leads and cables to measure the segment, which causes patient discomfort, increases complexity, makes the system unwieldy, and / or increases the risk of measurement errors. There is a risk.

The improvements provided by at least some implementations of the systems, methods, devices, and / or code instructions described herein are the numerous individual conductors and / or individual required by existing systems and methods. It is addressed by performing a segment impedance measurement approach without the need for electrodes and / or by the ability to measure the impedance of internal body organs such as the lungs. The reduction in the number of conductors and / or electrodes is due to the address architecture described herein, which is a small number as opposed to the existing method in which each electrode is connected by its own set of dedicated wires. Conductors, such as 5 or less than 10 conductors, can be used to select a particular electrode (eg, of a particular contact component).

At least some implementations of the systems, methods, devices, and / or code instructions described herein are bioelectrical impedance under conditions where standard impedance measurement processes are inaccurate and / or cannot be used. It improves the technique of bioelectrical impedance measurement and / or analysis by enabling measurement and / or analysis. In some cases, the optimal posture of the patient making the impedance measurement is the complete supine position. However, due to clinical constraints, for example, patients undergoing head injury and / or intracranial pressure monitoring, and / or the location of the electrodes due to the presence of other devices (eg, venous cannulas and flexible restraints). In the case of patients with altered, the patient may not be placed in full supine position. At least some implementations of the systems, methods, devices, and / or code instructions described herein allow electrodes to be placed anywhere on the body and / or electrodes placed on the body. The number may be large and / or by selecting different electrodes, it is possible to perform bioimpedance measurements on any part of the body.

Electrodes can be placed anywhere on the patient's body when connected to contact components, which are physical structures connected to a common busbar.

The data thus collected (i.e., as described herein, body segment impedance measurements, optionally per body segment impedance measurements) can be combined with data from other sensors, eg, body segments. Explained with reference to data from breathing, resting energy consumption, pressure sensors, pulse sensors, sound sensors, and skin conductance sensors, and / or international patent application IL2017 / 051271 by the same inventor as the present application. Correlation between muscle mass (ie, loss and / or increase) and nutrient consumption / delivery / change by ICU patients via an artificial intelligence (AI) model, in combination with such nutrient and liquid feeding rates. In the analysis, it can be used together with the analysis of the components in the feeding material. Since different body segments can have different rates of change in muscle mass and / or health, how feeding to muscle and / or other health in each body segment at the discretion of each body segment. Feeding may be correlated with the data to provide an indicator of the effect. For example, muscle mass may increase or decrease more proportionally in peripheral tissue compared to central tissue and vice versa. Muscle mass and hydration status are considered to be important indicators of clinical health and recovery, and therefore patient treatment should be adjusted for the improvement of said muscle mass, the methodology described above. Makes it possible. In comparison, known processes for adapting muscle mass and hydration status are simple manual operations such as weighing a patient with a scale, a simple blood test, and / or measuring the thigh circumference. It is a method by.

The analysis may indicate the effect of body intake and specific food content on specific body parts, as analyzed by impedance (and / or other) body sensors.

Optionally, an increase and / or decrease in muscle mass is optionally monitored for each body segment (eg, continuously tracked), and body intake and said muscle mass are optionally correlated for each body segment. Close-loop optimal control by applying an AI-based model allows dynamic changes in enteral and / or parenteral administration of food and / or liquid. Feeding speed, for example, to prevent and / or reverse muscle loss, and / or to adjust feeding to help the patient gain muscle (eg, recover from muscle loss). Instructions for execution by the feeding pump can be optionally generated dynamically and / or in real time to change the type of food and / or food. For example, the amount of lipids, carbohydrates, proteins, and fats contained in the food administered is controlled in response to changes in muscle mass. The amount of lipids, carbohydrates, proteins, and / or fats is based on a correlation dataset that correlates between changes in muscle mass and the amount of lipids, carbohydrates, proteins, and / or fats to be administered to a patient. And / or with specific physiological and / or demographic parameters. Different body segments may require different proportions of lipids, carbohydrates, proteins, and fats, for example, central tissues with a high proportion of fat (eg, abdomen), peripherals with a relatively high proportion of muscle. It may require different proportions of nutrients compared to the tissue of the department. The amount may be selected for each body segment using a correlation dataset that correlates between changes in muscle mass and the amount of lipids, carbohydrates, proteins, and fats. The amount per body segment may be summed up to obtain the overall amount / mixture of nutrition to be administered to the patient (eg, in addition, optionally, with weights for different body segments). The controller, for example, a total nutrition (eg, a mixture of nutrients and / or a dose and / or a dose and / or a rate and / or a pattern of administration) to be administered to the patient, based on the nutrition determined for each segment. Instructions for automatic (and / or manual and / or semi-automatic) delivery by the feeding pump may be generated.

For example, modifications as described with reference to International Patent Application No. IL2017 / 051271 may be applied to feeding pump speeds and / or food specifications.

Prior to elaborating on at least one embodiment of the invention, the invention, in its application, details and / or methods of structural details and components described in the following description, and / or drawings and /. Or it should be understood that it is not necessarily limited to those shown in the examples. The present invention can be implemented or practiced in other embodiments or in various ways.

The present invention may be a system, method, and / or computer program product. The computer program product may include one or more computer readable storage media having computer readable program instructions for causing a processor to perform aspects of the invention.

The computer-readable storage medium can be a tangible device that can hold and store instructions for use by the instruction execution device. The computer-readable storage medium may be, for example, an electronic storage device, a magnetic storage device, an optical storage device, an electromagnetic storage device, a semiconductor storage device, or any suitable combination described above, but is not limited thereto. A non-exhaustive list of more specific examples of computer-readable storage media is the following: Portable Computer Diskettes, Hard Disks, Random Access Memory (RAM), Read Only Memory (ROM), Erasable Programmable Read Only Memory (EPROM or Flash memory), static random access memory (SRAM), portable compact disk read-only memory (CD-ROM), digital versatile disk (DVD), memory stick, floppy disk (registered trademark), punch cards and grooves with recorded instructions. Includes mechanically encoded devices such as raised structures within, and any suitable combination described above. Computer-readable storage media as used herein are, for example, radio waves and other freely propagating electromagnetic waves, waveguides and other transmission media propagating electromagnetic waves (eg, optical pulses through optical fiber cables). Or it is not interpreted as a transient signal in itself, such as an electrical signal transmitted over a wire.

The computer-readable program instructions described herein are from computer-readable storage media to their respective computing / processing devices or via networks such as the Internet, local area networks, wide area networks and / or wireless networks. It can be downloaded to an external computer or external storage device. The network may include copper transmission cables, optical transmission fibers, wireless transmissions, routers, firewalls, switches, gateway computers and / or edge servers. The network adapter card or network interface of each computing / processing device receives computer-readable program instructions from the network and transfers the computer-readable program instructions for storage on the computer-readable storage medium within each computing / processing device.

The computer-readable program instructions for performing the operations of the present invention are assembler instructions, instruction set architecture (ISA) instructions, machine language instructions, model-dependent instructions, microcodes, firmware instructions, state setting data, or Smalltalk, C ++. Either source code or object code written in any combination of one or more programming languages, including object-oriented programming languages such as, and traditional procedural programming languages such as the "C" programming language or similar programming languages. It may be. Computer-readable program instructions are partly on the user's computer when executed entirely on the user's computer, partly on the user's computer, and partly on the user's computer when executed as a standalone software package. It may be run, partly on a remote computer, or entirely on a remote computer or server. In the latter scenario, the remote computer may be connected to the user's computer via any type of network, including a local area network (LAN) or wide area network (WAN) (eg, an internet service provider). It may be connected to an external computer (using it via the Internet). In some embodiments, electronic circuits including, for example, programmable logic circuits, FPGAs (Field-Programmable Gate Arrays), or PLAs (Programmable Logical Arrays) personalize electronic circuits to carry out aspects of the invention. As described above, the computer-readable program instruction may be executed by using the state information of the computer-readable program instruction.

Aspects of the invention will be described herein with reference to flowcharts and / or block diagrams of methods, devices (systems), and computer program products according to embodiments of the invention. It will be appreciated that each block of the flowchart and / or block diagram, as well as the combination of blocks of the flowchart and / or block diagram, can be performed by computer-readable program instructions.

These computer-readable program instructions are provided to the processor of a general purpose computer, special purpose computer, or other programmable data processing device, and the instructions executed through the processor of the computer or other programmable data processing device are shown in the flowchart and /. Alternatively, a machine can be produced that creates a means of performing a function / activity specified by one or more blocks in a block diagram. Also, these computer-readable program instructions may be stored on a computer-readable storage medium that can instruct the computer, programmable data processor, and / or other device to function in a particular way. , The computer-readable storage medium having the instructions stored therein constitutes a product containing instructions that perform the mode of function / activity specified in one or more blocks of the flowchart and / or block diagram.

Also, computer-readable program instructions are loaded onto a computer, other programmable data processing device, or other device, and instructions executed on the computer, other programmable device, or other device can be flow charts and instructions. / Or a series of operation steps, such as implementing a function / activity specified by one or more blocks in a block diagram, can be run to spawn a computer-implemented process.

The flowcharts and block diagrams in the figure show the architecture, function, and operation of possible implementations of systems, methods, and computer program products according to various embodiments of the invention. In this regard, each block in the flowchart or block diagram may represent part of a module, segment, or instruction, which is one to implement one or more specified logical functions. It has one or more executable instructions. In some alternative implementations, the features described in the blocks may be out of order as shown in the figure. For example, two blocks displayed in succession may actually be executed at substantially the same time. The blocks may also be executed in reverse order, depending on the functionality involved. Also, each block of the block diagram and / or the flow chart, and the combination of the blocks of the block diagram and / or the flowchart diagram, performs a specified function or activity, or is a combination of special purpose hardware and computer instructions. Also note that it can be implemented by a special purpose hardware-based system to run.

Here, with reference to FIG. 1, of a plurality of contact components (eg, 114A-B) connected by a multimedia bus bar (also referred to herein as a bus bar) according to some embodiments of the invention. To measure the body composition of one or more body parts of a patient by selectively activating electrodes 118 (eg, of electrode components) of a particular contact component (eg, 114A). It is a schematic diagram of the system 100. According to another embodiment, other sensors such as pressure, temperature, skin conductivity and pulse piezo sensors may be connected to the busbar in addition to and / or as separate entities to the impedance electrodes. Also shown in FIG. 2 is a flow chart of a computer implementation method for selectively activating an electrode of a contact component among a plurality of contact components connected by a bus bar according to some embodiments of the present invention. refer. Electrode 118 of contact components 114A-B (optionally within the electrode components including secondary components such as address decoders and / or switches as described herein) is optional. There are three for each contact component, and they may be arranged along the long axis (that is, substantially a straight line) of each contact component at intervals. One or more activities of the method described with reference to FIG. 2 are code instructions 106A stored, for example, in a program store (eg, memory) 106 by a component of system 100, as described herein. It may be implemented by one or more processors 102 of the computing device 104 that performs the above.

The computing device 104 is coupled with a controller 108 (eg, eg, a controller 108) that generates an instruction to select an electrode 118 on a particular contact component (eg, 114A) from a plurality of contact components (eg, 114A-B). It communicates electrically with a transmitter and receiver component, or a separate transmitter and receiver component 108). Each set of electrodes 118 on each contact component (eg, 114A-B) is connected to a bus bar 112.

As used herein, the term electrode (eg, 118) may sometimes replace the term electrode component, and / or, as described herein, an address decoder circuit and / or switch, or. It may refer to an electrode of an electrode component that contains additional secondary components such as other biosensors.

Each contact component is composed of, for example, a flexible printed circuit board, plastic, cloth, etc., and is optionally flexible. Each contact component may include a surface for placement with respect to the patient's body and may optionally be placed with respect to the skin. The surface may contain an adhesive.

Optionally, one bus bar 112 connects all electrodes on all contact components. Alternatively, a plurality of bus bars 112 are used, where each bus bar 112 connects two or more contact components to the coupled electrodes. Each busbar 112 may mount, for example, a plurality of conductive wires (eg, strips of wire, metal or other good conductive material) and, optionally, a single wire for each dedicated task, eg, a book. Lines may be implemented for each of current, ground, power, voltage detection, and / or addressing as described herein.

Note that there are multiple contact components. As an example, two contact components 114A-B are drawn. Each contact component may include the same or different number of electrodes 118 on it. Optionally, each contact component comprises three electrodes 118 and is optionally spaced along an axis (ie, substantially a straight line).

The controller 108 injects an electrical signal into the electrode assigned as the current electrode of the contact component selected by the address code and receives the signal from the electrode of another contact component assigned as the detection electrode by the address code. The transceiver may include, for example, a signal is injected into one electrode of one contact component acting as a transmitter, and measurement of the received signal by another electrode of another contact component is performed. The computing device 104 generates instructions for operating the controller 108 and / or optionally receives data from the controller 108 via the device interface 110. Alternatively, the computing device 104 and the controller 108 are implemented as a single device, and / or the controller 108 is, for example, as another hardware component and / or code installed on the computing device 104. Is integrated into the computing device 104. When the computing device 104 and the controller 108 are integrated, the device interface 110 may be, for example, an internal software interface.

Optionally, each biosensor is assigned a unique address. The biosensor is connected to a multimedia bus bar connected to at least some electrodes. The controller operates the biosensors and electrodes by transmitting a specific unique address on the multimedia bus bar, as described herein.

Outputs from other biosensors connected to the multimedia bus bar may be combined with impedance measurements for display and analysis.

The addressing instruction output by the controller may define the operation of the corresponding electrode as a current carrier or voltage sensor.

Different components may be individually connected to the controller, resulting in a mixed connection.

Optionally, contact components with corresponding electrodes are placed in one or more body tubes 130. In another embodiment, the contact component is mounted as a body tube 130. The body tube 130 makes it possible to obtain measurements of the composition of body parts within the body, such as the lungs (eg, to measure edema). Examples of the body tube 130 are, for example, U.S. Patent Application No. 16 / 467,078, U.S. Patent Application Publication No. 2010/0030133, U.S. Pat. As described with reference to Patent Application No. 14 / 986,831 and US Patent Application No. 16 / 000,922, Intratracheal Tube (ETT), Nasal and Gastric Tube (NG), Other Feeding Tubes, Cauters. , And / or other tubes designed to be inserted into the body.

Optionally, the computing device 104 is implemented as hardware such as, for example, circuits, assembly of hardware components, integrated circuits, and / or other architectures. Alternatively or additionally, the computing device 104 can be, for example, a stand-alone unit, hardware component, client terminal, server, computing cloud, mobile device, desktop computer, thin client, smartphone, tablet computer, laptop computer, wearable. It may be implemented as a computer, a glasses computer, and a clock computer. The computing device 104 may include locally stored software and / or hardware that perform one or more of the activities described with reference to FIG.

The processor 102 of the computing device 104 is, for example, a central processing unit (CPU), a graphics processing unit (GPU), a field programmable gate array (FPGA), a digital signal processor (DSP), and an application specific integrated circuit (ASIC). It may be implemented as. The one or more processors 102 may include one or more processors (similar or heterogeneous), which may be used as a cluster for parallel processing and / or as one or more multi-core processing units. It may be arranged.

As used herein, the term "processor" may be replaced with the term "computing device".

The storage device 106 (also referred to herein as a program store, eg, memory) stores code instructions that can be implemented by one or more processors 102, eg, random access memory (RAM), read-only memory. (ROM) and / or storage devices such as non-volatile memory, magnetic media, semiconductor memory devices, hard drives, removable storage, and optical media (eg, DVD, CD-ROM). The storage device 106 stores code instructions 106A that perform one or more activities of the methods described with reference to FIG. Alternatively or additionally, one or more activities of the method described with reference to FIG. 2 are implemented in hardware.

The computing device 104 comprises data, eg, impedance measurements obtained from electrodes of different contact components for measuring body composition of a patient's body part, and / or generated measurements (eg, body composition values). ), And / or an index of the measured value analyzed (eg, a value of a clinical parameter), and / or a data repository 116 for storing a data set containing the trend of the measured value. The data repository 116 is, for example, a memory, a local hard drive, a solid state memory device, a removable storage unit, an optical disk, a storage device, and / or a remote server and / or a computing (eg, accessed via a network connection). It may be implemented as a wing cloud.

The computing device 104 is a mechanism for the user to enter data (eg, patient information) and / or view the displayed data (eg, optionally a measurement of the composition of different body parts in the GUI). User interface (and remote storage-processors such as the cloud) 118, including, and / or communicating with it wired or wirelessly. An exemplary user interface 118 includes, for example, one or more of voice activation software using a touch screen, display, keyboard, mouse, and speaker and microphone. An external device that communicates with the computing device 104 may be used as a user interface 118, for example, a smartphone running an application may use a communication interface (eg, a network interface, a cellular interface, a short range wireless network interface). And communication with the computing device 104 (eg, cellular, network, short range radio) may be established.

The computing device 104 includes a device interface 110 that provides telecommunications with one or more controllers 108. The device interface 110 provides, for example, a network interface card, a hardware interface card, a wireless interface, a physical interface for connecting to a cable, a virtual interface implemented in software, and higher layer connectivity. It may be implemented as communication software (eg, Application Programming Interface (API), Software Development Kit (SDK)), and / or other implementations.

The computing device 104 may include a network interface 120 for connecting to the network 122, for example, a network interface card, a wireless interface for connecting to a wireless network, and a physical for connecting to a cable for network connection. Includes one or more of interfaces, software-implemented virtual interfaces, network communication software that provides higher layers of network connectivity, and / or other implementations.

The computing device 104 is, for example, a network 122 (or a direct link (eg, cable, wireless) and / or an indirect link (eg, via an intermediate computing device such as a server and / or via a storage device). Another communication channel, such as through), may be used to communicate with one or more client terminals 124 and / or one or more servers 126. For example, the server 126 may receive data collected from the electrodes 118 by the controller 108 and calculate the composition of one or more corresponding body parts of the patient. The server 126 may provide centralized computing services to a plurality of remote controllers 108 (and / or remote computing devices 104). Server 126 detects signs of anomalies, for example, by a machine learning model trained using data obtained from multiple sample patients (eg, via their respective remote computing devices 104 and / or controller 108). And / or data may be analyzed to predict future anomalous composition. The client terminal 124 may connect to the server 126 and / or the computing device 104 via the network 122. For example, an image calculated by the server 126 using the data collected by the computing device 104 is provided for display on the display of the client terminal 124. In another example, the computing device 104 and / or the server 126 may include additional patient data, such as measurements made by other modality, imaging results obtained from other imaging modality, and / or patient. Medical history data obtained from electronic medical records may be acquired. Additional data may be used to analyze the measured compositional portion of a patient, for example, to improve the accuracy of detection and / or prediction of certain clinical conditions such as edema.

Referring to FIG. 2, at 202, a system setup is provided and / or selected.

One or more different parameters of the system can be selected and / or adjusted as follows.

The number of contact components can be optionally selected. The number of contact components can be selected depending on the number and / or position of body parts monitored and / or measured. Each contact component is placed at the outer edge of each body segment that is monitored and / or measured. Body segments may overlap each other and the same contact components can be used for different body segments, reducing the number of electrodes used for monitoring.

Contact components are independent physical structures that can be independently placed in different positions on the body. The contact components are spaced apart. With the exception of flexible busbars, the contact components are not physically connected, so placing one contact component on one body part is another contact component on another body part. It can be done without affecting the position of.

Each contact component comprises a patient's body, optionally multiple electrodes for contact with the skin. Optionally, each contact component comprises three electrodes, optionally located along the long axis of the contact component.

Optionally, each contact component is associated with a unique address. All electrodes of the contact component may be selected by the same unique address. The electrodes of a contact component with a unique address are independently (eg, as a current source, current sink, voltage sensor, and other biosensor) by a command issued by the controller to the unique address of the contact component. It may work. Alternatively, each electrode is associated with an electrode structure having its own address recognized by the address decoder. Each electrode can operate independently by the controller issuing an operation instruction to a unique address of each electrode.

Optionally, each contact component includes a connector for connecting to the busbar, optionally reversibly allowing removal from the busbar. Contact components can be added (ie, connected) to and removed from the busbar as needed, for example, to monitor different body segments of different patients. The bus bar may also be pre-attached to the contact component in such a way that the contact component cannot be removed from the bus bar without disconnecting the connection.

Optionally, the number of busbars is selected. Optionally, at least one bus bar is connected to two or more electrodes (or electrode structures) of the two or more contact components. The electrodes can be selected and operated using the same common busbar via the address of the target electrode (and / or target contact component). Optionally, a single main busbar is used and all contact components are connected to the main busbar. Alternatively, two or more busbars are used, for example, one busbar is connected to the patient's left contact component and another is connected to the patient's right contact component.

Optionally, one or more body probes for insertion into the patient's body, optionally tube selection and / or designation. The body tube is one or more contact components with multiple electrodes, or electrodes and related if the tube itself acts as a contact component (ie, the term contact component may refer to a tube). Circuits are coupled and / or included on top of it. The electrodes and / or contact components of the tube can be connected to one of the busbars and can be addressed by the controller as described herein. Optionally, the busbar connects the electrodes of the tube (ie, the contact component) with one or more other contact components located outside the patient's body (eg, on the skin). Exemplary contact components include, for example, U.S. Patent Application No. 16 / 467,078, U.S. Patent Application Publication No. 2010/0030133, U.S. Patent Application No. 14/986,831 by the same inventor as this application, and U.S. Patent Application Nos. 16 / 000, 922, which are incorporated herein by reference in their entirety, endotracheal tube (ETT), feeding tube, and nasogastric tube (NG). Is included. Current and / or voltage may be measured between an electrode of the tube and another electrode on the contact component on the surface of the patient's body, eg, the electrode of the tube and the contact component in contact with the skin. The impedance measurements made by and indicate the body composition of the lung, eg, the amount of fluid in the lung and / or the type of fluid in the lung.

Optionally, some electrodes are connected to the controller via an addressing busbar and some electrodes are individually connected and assigned to the controller via a conductor, ie, a mixed interface of electrodes and biodetection elements. It is a connection.

Here, reference is made to FIG. 3, which is a schematic diagram illustrating an exemplary architecture of an addressable electrode component 302 (also referred to as an electrode activation circuit) according to some embodiments of the present invention. In an exemplary implementation, the plurality of electrode components 302 are part of the contact component 304 and, optionally, three electrodes along the long axis of the contact component 304, as described herein. It is a component 302.

Each electrode component 302 sends an electric current to an address decoder secondary component (eg, circuit) 302A for identifying the unique address of each electrode component 302 transmitted on the multimedia bus bar 304. Multiply the electrode 302B in response to a trigger by the electrode 302B, which is capable of receiving current and / or operating to measure voltage, and the address decoder 302A, which recognizes a unique address on the address line of the multimedia bus bar 306. It comprises a switch secondary component 302C (eg, a circuit) that connects to the relevant line of the conductor bus bar 306. Additional optional secondary components of the electrode component 302 include an amplifier for amplifying measurements (eg, voltage, current) by the electrode or other optional sensor 302B, and / or a multimedia bus bar. A secondary component that obtains commands for the operation of the electrode 302B received from the relevant line of 306, for example, a secondary component that operates the electrode 302B as a current source, a current receiver, and / or a voltage sensor. Contains components.

The multimedia bus bar 306 connected to the controller is a Vcc line for transmitting power to one or more of the following secondary components (eg, as conductive lines), electrode components 302, respectively, for dedicated tasks. 306A, current injection line 306B for transmitting current to an electrode operating as a current source, voltage detection line 306C for receiving voltage measurements by an electrode operating as a voltage sensor, grounding 306D for operating as global grounding, And may include an address line 306E for transmitting a unique address for selection and operation of a particular electrode structure. Additional optional lines include command lines for sending commands for the mode of operation of electrodes with unique addresses (eg, current sources, current sinks, voltage sensors), and / or electrodes that act as current sinks. It may include a current receiving line for receiving the current received by the sensor, and one or more lines connecting other sensors.

Here, reference is made to FIG. 4, which is a schematic implementation of an exemplary implementation of two contact components 404 coupled to the same multimedia bus bar 406, according to some embodiments of the invention. Optionally, multiple contact components and busbars are integrated into a single physical structure, optionally, long strips made of, for example, flexible printed circuit boards, where each contact component is a different part of the body. It may be arranged independently in. Each contact component 404 comprises three electrode components 402, each containing an electrode 404B, one or more switches 402C, an address encoder 404A, and other optional components described herein. include. Busbar 406 includes + 5V DC line 406A, serial address line 406E, current line 406B, V1 line 406C, V2 line 406F, and ground line 406D.

In the present specification, for example, when each electrode can be addressed, the term electrode component may be replaced with the term electrode.

Now, return to FIG. At 204, the contact component is attached to the patient's body. The contact component may be attached, for example, by an adhesive surface that adheres to the patient's skin. Electrodes located beside the adhesive surface are placed in contact with the skin. In another example, the contact component may, for example, bandage the contact component and the limb, or place the contact component between the compression stocking and the patient's foot to provide an outer and / or external connector. Attached via. A tube that acts as a contact component (or on which the contact component is mounted) can be inserted into the patient's body.

Optionally, the busbar is connected to the contact component before and / or after attaching the contact component to the patient's body. Alternatively, the bus bar may be pre-attached to the contact component. Busbars may be flexible so that they can be used with patients of various sizes.

Optionally, electrodes (eg, three) placed along the long axis of each contact component are placed and positioned on the patient along a virtual straight line drawn on the surface of the patient's body. To. For example, along an imaginary straight line running from the heel to the wrist, the contact component is along a long axis parallel to this virtual straight line, eg, on the ankle (eg, from the foot to the head), the wrist. It is placed on top (for example, from the palm to the elbow).

By arranging the electrodes along a virtual straight line, for example, the controller injects current along the boundaries of the body segment using the intermediate electrodes of each contact component of the set of contact components. Can be received and the voltage measured using the inner facing electrode of the set of contact components. When monitoring another body segment with one of the contact components already used for other body parts, the intermediate electrode is used to reinject and receive the current and the inner counter electrode is used to apply the voltage. As measured, one of the current inner facing electrodes may function as the outer facing electrode for measuring the other body segment. For example, by placing contact components on the wrist, ankle, and chest, the wrist-chest, chest-ankle, and wrist-ankle segments can be measured using three electrodes on the three contact components. can. The chest electrodes and contact components allow the wrist-chest and chest-ankle segments to be measured as separate segments in contact with each other.

Another option is to inject current into the two outermost electrodes from the wrist to the ankle and detect the voltage from the individual body segments.

Optionally, the body can be empirically considered to consist of the following segments, each having uniform conductivity, the limbs (left arm, right arm, left leg, right leg) and the trunk. Contact components can be placed to measure the impedance of one or more of these segments.

Exemplary installation locations for contact components include wrist, ankle, chest, metacarpal bone line, metatarsal bone line, elbow, shoulder, armpit, knee, buttocks, neck, along the axillary line, along the clavicle line. Things are included.

Here, an independently addressable, arranged contact component 502 on a common multimedia bus bar 504 for monitoring multiple body segments of a patient, according to some embodiments of the invention. See FIG. 5, which is a schematic diagram showing the above. Contact components (with 502 attached to one for clarity) are shown as being placed on the wrists, shoulders, thighs, and ankles, as a non-limiting example. Each contact component 502 includes three electrodes 506 arranged along the long axis of each contact component. The measurement console 508 acts as a controller for operating the electrodes 506 of the contact component 502 via addressable instructions transmitted via the common bus bar 504. Impedance measurements may be analyzed and displayed on display 514, for example as a piccoli ellipse and / or as drawing a trend arrow superimposed on a piccoli chart. Optionally, the electrode 510 is placed in the esophagus, eg, on a feeding tube. Electrodes 510 may be used to measure the impedance of internal segments, such as lungs, as described herein. The electrode 510 may be connected to the main bus bar 504 or may be connected to another bus bar 512. Electrodes 510 may be independently addressable and / or operable by the controller as described herein.

Here, reference is made to FIG. 6, which is a schematic diagram based on the setup described with reference to FIG. For example, electrodes are placed on it for impedance measurements and / or pulmonary water content measurements for cardiac output estimation (indicated by arrow 604) according to some embodiments of the invention. Includes additional contact components 602. The contact component 602 may be placed close to and / or above the patient's heart, for example, at the base of the neck as shown. The impedance measured using the electrodes of the contact component 602 and the electrodes 510 placed in the esophagus is a non-invasive or minimally invasive method for the calculation of cardiac output using bioimpedance ECG. It may be analyzed, which is compared to standard approaches to measuring absolute cardiac output (eg, using sensors located within the heart and / or circulatory system). It may perform well as a volume trend analysis. The setup depicted is a 4-terminal impedance monitoring setup (1 terminal is an address).

Here, in addition to the contact components placed on the right side of the patient's body as in FIGS. 5 and 6, according to some embodiments of the invention, they are placed on the left side of the patient's body (clearly). See FIG. 7, which is a schematic diagram based on the setup described with reference to FIG. 6 (and FIG. 5), including additional contact components (labeled one contact component 702 for the sake of sex). .. By placing the electrodes on both sides of the patient's body and optionally inside the patient (eg, in the esophagus), both sides of the body and / or the central part of the body (eg, the contact component on the left side and the right side). With other contact components), the impedance of many different body segments defined by the set of ends of the selected contact component can be measured.

Next, according to some embodiments of the present invention, each contact component (labeled on one contact component 810 for clarity) is a main multimedia conductor via an individual cable 806. See FIG. 8, which is a schematic diagram of the architecture 802 connected to the bus bar 804. The controller 808 sends instructions to the selected contact component (and receives measurements from the contact component) via the main bus bar 804 and the individual cables 806, via the addresses of the respective contact components. .. A single main busbar 804 may be used, with two or more main busbars, eg, one busbar connecting to a cable of contact components located on the left side of the body, and a contact configuration located on the right side of the body. You may use another busbar, which connects to the element's cable. Electrodes on the body tube (eg, on the feeding tube located in the esophagus) are connected to one of the main busbars. Contact components may be placed on both sides of the body, as described with reference to FIG. Also, as described herein, some of the electrodes are connected to addressable busbars, while the other electrodes may be individually connected in a more conventional way.

Here, according to some embodiments of the present invention, each electrode (one electrode 910 labeled for clarity) is connected to the main multimedia bus bar 904 via individual cables 906. See FIG. 9, which is a schematic diagram of the architecture 902. Each electrode 910 may be associated with its own contact component, or multiple electrodes 910 may be associated with a single contact component (eg, two or three for each contact component). , Or more electrodes), or electrodes 910 are placed directly on the patient without contact components. Each electrode 910 may be part of an electrode component that includes an addressing circuit for recognizing the unique address of each electrode, as described herein. The controller 908 sends instructions (and receives measurements from the electrodes) to the selected electrodes via the main bus bar 904 and the individual cables 906 and through the addresses of the respective electrode components. Each electrode is subject to the selected mode of operation (eg, current source, current sink, and / or voltage measurement sensor or other) according to the command and associated address of the selected electrode transmitted via the main bus bar 904 by the controller 908. It may be instructed to operate with a biosensor). A single main busbar 904 may be used, with two or more main busbars, eg, one busbar connecting to a cable of electrode components located on the left side of the body, and an electrode configuration located on the right side of the body. You may use another busbar that connects to the element's cable. Electrodes on the body tube (eg, a feeding tube located in the esophagus) are connected to one of the main busbars. Electrode components may be placed on both sides of the body. For example, in order to measure the impedance Z1, the electrode E1 is instructed to operate as a voltage sensor and the electrode E2 is instructed to operate as a current electrode. In another example, in order to measure another impedance Z2, the electrode E1 is instructed to operate as a current electrode and E2 is instructed to operate as a measuring electrode. To measure the impedance, the electrodes that transmit and / or receive the current are placed behind the electrode that measures the voltage so that the current transmitted to and / or from the current electrode passes through the electrode detection voltage. Please note that. Contact components with three electrodes spaced apart in the major axis direction improve impedance measurements by the relative placement of current-operated and voltage-operated electrodes, as described herein. Designed to.

Here, in a schematic diagram showing an exemplary contact component 1002 placed in contact with the patient's skin 1004 to measure the impedance of a body segment containing tissue 1006 according to some embodiments of the invention. Refer to a certain FIG. The contact component 1002 includes three electrode components (sometimes also referred to as electrodes) arranged along the long axis of the contact component 1002. The contact component 1002 may include, for example, a support strip 1010 that connects to the electrode component 1008 as a flexible printed circuit board, plastic, cloth, fabric and / or other material. Each electrode component 1008 may include an address decoder 1008A, an electrode 1008B, and one or more switches 1008C as described herein.

At 206, the body segment is selected for its impedance measurement. Each body segment may be measured sequentially. In the optional selection, the innermost / smallest segment is selected first, followed by the larger segment that contains the inner / smaller segment and / or overlaps the inner / smaller segment. For example, first measure the wrist-chest segment, then the chest-ankle segment (or vice versa), and then the wrist-ankle segment. Alternatively, the larger segment is measured first, then the smaller segments that are located and / or may overlap in the larger segment. For example, first measure the wrist-ankle segment, then measure the wrist-chest and / or chest-ankle segment. Optionally, the selected segments are placed inside the body, eg, the lungs and / or the heart (eg, to estimate heart rate using impedance ECG as described herein). To. Internal segments can be measured using electrodes placed inside the body on a probe (eg, a tube) such as a nasogastric tube placed in the esophagus, as described herein. ..

Here, in order to aid in the understanding of some embodiments of the present invention, reference is made to FIG. 11, which is a schematic diagram showing an example of the measurement of the whole body segment 1102 and the measurement of the leg segment 1104. Whole-body impedance (denoted as Z) may be measured, for example, by an electrode 1106 located on the wrist and another electrode 1108 located on the ankle. Further, the impedance of the leg (denoted as z) is measured by, for example, an electrode 1110 arranged on the upper part of the leg (for example, the thigh and the buttocks) and another electrode 1112 arranged on the ankle of the leg. You may. Impedance measured for a body segment (eg, legs, such as 1104) may be more than 10 times more sensitive than impedance measured for the entire body (eg, 1102). Note that the values obtained using the setup shown in 1102 correspond to the impedance measurements of the BIVA type.

Here, to help understand the improved accuracy of the impedance measured for the body segment as compared to the whole body, reference is made to FIG. 12, which includes a piccoli diagram for the whole body measurement 1202 and the body segment 1204. Piccoli FIG. 1202 for the whole body, where the whole body segment measurement setup 1102 of FIG. 11 may be used, shows the angular change due to the local impedance change marked α _A. Piccoli FIG. 1204 for a body segment in which the leg body segment measurement setup 1104 of FIG. 11 may be used shows an angular change due to a local impedance change, marked α _B. The increase in sensitivity of segment measurements to whole body measurements is noted as α _A >> α _B.

At 208, the controller selects, activates and / or operates a set of contact components (and / or electrodes thereof) connected by a common multimedia bus bar. Each electrode of the contact component may be selected, activated and / or operated. The selection and activation and / or operation may be performed sequentially, for example, a set of first members, followed by a set of second members.

Exemplary operating modes include current sources, current sinks, voltage sensors, and other biosensors.

The controller sends a unique address of a particular contact component (and / or its electrode) on the busbar, eg, on the address line component of the busbar, so that the particular contact component (and / or its electrode). Generates and sends instructions for activation and / or operation of. The operation instruction in a specific operation mode may be transmitted in association with a unique address, for example, on another line component of the bus bar. The circuit of the contact component corresponding to the unique address executes the instruction (eg, to operate in the specified mode of operation).

Other contact components (and / or electrode components) may listen to the busbar for an address and ignore the instruction if no address is assigned. The address may be defined, for example, by a set of sequential and / or parallel signal bits transmitted over the busbar (eg, via the busbar's dedicated address line component).

At 210, one or more impedance measurements of the selected body segment are obtained from a set of contact components (ie, from their electrodes). Optionally, voltage and current measurements are obtained from a set of contact components. Impedance measurements are calculated from the obtained voltage and current measurements.

The applied currents are alternating current (AC) and / or direct current (DC).

Optionally, in another embodiment, the electrodes and / or sensors optionally have a double wall (eg, made of fabric, plastic, and / or other material or combination of materials) of the inner wall of the sleeve. It may be mounted inside. The sleeve can be worn on a part of the patient's body. At the time of use, when the sleeve is attached to the body, the electrodes come into contact with the patient's body, optionally the skin. The electrode components are connected to the controller via a bus bar and optional cables, as described herein. The lumen formed by the double wall may be inflated. The inflated lumen can increase and / or guarantee the accuracy of pressure that is substantially uniform and equal to all electrodes for a more uniform measurement. Expansion may be controlled by a controller via a pump connected to the expansion tube of the sleeve.

Also, by attaching a plurality of sensor strips to a part of the patient's body with an adhesive, for example, 3D impedance mapping of the part of the body can be performed in both embodiments.

Here, reference is made to schematic view 1800A of a cross section of a patient's foot and FIG. 18 comprising an inflatable sleeve 1802 with electrodes 1804 disposed within the inner wall of the sleeve, according to some embodiments of the invention. The sleeve 1802 includes a bus bar 1806 and / or an expansion tube 1808 that connects to the controller, as described herein. FIG. 18 also includes schematic view 1800B of a cross section of a foot having electrodes 1850 (eg, spaced electrodes on contact components) on conductor strip 1852, according to some embodiments of the invention. There may be multiple conductor strips 1852 connected to a single main bus bar 1854. Each strip 1852 of the electrode 1850 may be independently placed on the leg by an adhesive. Schematic drawings 1800A and 1800B may be combined, where the strips of electrodes are positioned within an inflatable sleeve using, for example, Velcro®, straps, and / or other connecting materials. Please note that.

Optional different current frequencies-multi-frequency, eg, in the range of about 10 Hz, 100 Hz, 1000 Hz (Hz) to 100 kHz (kHz), or 1 kHz to 1000 kHz, and optionally using a center frequency of 50 kHz. Multiple impedance measurements can be obtained. Exemplary frequencies include 1 kHz, 5 kHz, 50 kHz, 250 kHz, 500 kHz, and 1000 kHz. The frequency may be, for example, 1 kHz, 10 kHz, or an increment of other values, or may be a continuous measurement in which the frequency is continuously changed. 3D maps may be created and displayed using linear gradient measurements at different frequencies, as described herein.

The current (eg, AC and / or DC) may be sinusoidal or other pattern.

The current amplitude may be, for example, about 10, 100, or 200, or 400, or 1000 microamps, or any other value.

The exemplary current used to estimate the FFM is an AC sinusoidal current of 400 μA at a single operating frequency of 50 kHz.

Optionally, the calculated impedance will be a complex value. The real part (denoted as R) and the imaginary part (denoted as X) may be calculated.

This impedance provides an estimate of the body composition of the selected body segment.

At 212, one or more features described with reference to 206-210 are repeated. Optionally, iterations can obtain impedance values for one or more identical body segments over time to obtain impedance measurements for different body segments and / or by obtaining multiple impedance values over time intervals. It is for monitoring.

Optionally, the controller iteratively switches between different sets of contact components of different body segments to obtain impedance measurements over time intervals to monitor each of the body segments. For example, after obtaining one or more impedance measurements for one body segment, another set of impedance measurements for another body segment may be obtained for the first body segment and the second body segment. Repeat the cycle of measurements over time.

Optionally, the smaller segment can be measured first. Larger segments, including two or more smaller segments, may be measured later. Alternatively, the larger segment can be measured first, and then two or more smaller segments within the larger segment can be measured.

Alternatively, for example, a single segment may be selected to monitor lower leg hydration levels. Contact components in other segments are either electrically disconnected or otherwise not activated by the controller.

Optionally, the controller iteratively selects another (eg, a second) set of contact components from a set of contact components connected by a common multimedia bus bar. The first set of contact components may be located between the second set of contact components. For example, a first set of contact components is placed on the wrist and along the axillary centerline, and a second set of contact components is on the wrist (ie, the same wrist component as the first set) and Placed on the ankle. Alternatively, the first set and the second set are interchanged. The first and the second set of contact components are connected to the same common multimedia busbar.

Optionally, if the first set of contact components is placed between the second sets of contact components, the electrodes of the first set are placed between the second sets of contact components. It is not selected and activated during impedance measurements made for each body segment. One of the second set of contact components may be selected from the first set of contact components. For example, if the first pair measures the impedance of the body segment between the wrist and chest and the second pair measures the impedance of the body segment between the wrist and ankle, then the body segment between the wrist and ankle. During impedance measurements, contact components placed on the chest (ie, between the wrist and ankle) are not selected and activated. The wrist contact component can be used to measure the impedance of both the wrist-ankle and wrist-chest body segments.

An optional contact component architecture that includes three (or more) electrodes aligned along the long axis of the contact component, with optional all electrodes of the plurality of contact components. Along an optional straight line drawn on the patient's skin (the straight line may be a straight line along the skin, but note that it is curved depending on the features of the surface of the skin). For an aligned architecture, the controller may optionally inject and receive current using the intermediate electrodes of each of the first and second sets of contact components. good. Further, the voltage may be measured by using the inner facing electrodes of the first set and the second set of the contact components. For example, when measuring the wrist-chest and chest-ankle body segments, the intermediate electrodes of the chest contact components are used for electrical current. The wrist-chest segment uses the electrode closer to the wrist of the chest contact component, and the chest-ankle segment uses the other electrode closer to the ankle of the chest contact component. The wrist-ankle segment does not use the chest contact component.

Here, with reference to FIG. 13, which is a schematic diagram showing a process of selectively activating electrodes of a plurality of contact components for detecting a plurality of body segments according to some embodiments of the present invention. .. This process is performed by instructions transmitted from the controller via the busbar, as described herein. Contact components 1304, 1306, 1308 arranged with respect to the body of patient 1310 include three respective electrodes 1304A-C, 1306A-C, 1308A-C, respectively arranged along a longitudinal line. ..

Schematic 1302A shows the process of measuring the impedance of a body segment (denoted as A) between contact components 1304 and 1306. The intermediate electrode 1304B operates as a current injector and the intermediate electrode 1306B operates as a current collector, while the voltage is measured between the inner facing electrodes 1304C and 1306A.

Schematic 1302B shows the process of measuring the impedance of a body segment (denoted as B) between contact components 1304 and 1308. The intermediate electrode 1306B operates as a current injector and the intermediate electrode 1308B operates as a current collector, while the voltage is measured between the inner facing electrodes 1306C and 1308A.

Schematic diagram 1302C shows the process of measuring the impedance of a body segment (denoted as C) between contact components 1304 and 1308. Note that body segment C includes both body segments A and B. The outer electrode 1304A operates as a current injector and the intermediate electrode 1304 operates for voltage measurement. Alternatively, the intermediate electrode 1304B is operated as a current injector, the intermediate electrode 1308B is operated as a current collector, and the voltage is measured between the inner facing electrodes 1304C and L08A. In each case, the principle of operation is to have two current injection electrodes and two voltage detection electrodes between the two current injection electrodes, which is the preferred four-electrode approach to impedance detection.

At 214, the obtained impedance data is analyzed. The impedance data is a single measurement of a set consisting of multiple measurements at close intervals, such as measurements at different frequencies, for example, less than about 1 second, or 10 seconds, so that a real-time value is obtained. , Or 1 minute), or at large time intervals such as calculating trends (eg, about 10, 15, 30, 60, 120 minutes, 6, 12, 24, 48, 72 hours, 1 week). , Or other values).

Optionally, body composition is estimated for each body segment based on the impedance values obtained for each body segment. Exemplary body compositions include fat content, edema, water content, electrolyte content, and pathological conditions.

Alternatively or additionally, impedance measurements of one or more body segments are analyzed to see if the current goal has been reached, for example, if the body composition of each segment has reached a clinically significant goal. Is judged. Optionally, a warning will be generated when the goal is reached. For example, a pop-up notification appears on the display and / or a text message is sent to the on-duty mobile device.

Alternative or additional, impedance measurements of one or more body segments are analyzed, for example, predictions are made when the body composition of each segment reaches a clinically significant goal. For example, if a patient is expected to reach a goal within the next 15 minutes, a predictive warning instruction will be generated and provided. Forecasting is, for example, trend analysis (eg, the least squared fitting of a trend line to predict when a trend line crosses a threshold) and / or a machine learning model trained with indicators of data and results (eg, eg). It may be calculated by supplying data to a neural network).

Clinically important goals include dehydration and hypervolemia.

Impedance values can be analyzed to calculate the following exemplary health parameters.
ECW-Extracellular water, forming the main conductor of low frequencies.
-ICW-Intracellular water, high frequency and conductive.
TBW-Indicates total hydration and body hydration status.
FFM-Lean body mass.
% Body fat-an indicator of a patient's obesity status.

Other parameters, such as lung water content, are calculated as part of the general patient condition.

Here we refer to FIG. 14, which includes some exemplary BIS equations according to some embodiments of the invention.

Now refer to FIG. 15, which includes some exemplary equations for calculating exemplary health parameters according to some embodiments of the invention. Exemplary parameters may be calculated for each of the monitored body segments.

At 216, data and / or analyzed data are provided. The data and / or the analyzed data is displayed, for example, on a display within a graphical user interface (GUI) and stored in memory (such as in a patient's electronic health record and / or locally on a computing device). And / or may be provided to another process for further processing (eg, running locally and / or running on a remote server and / or cloud).

Optionally, the body composition of each body segment is displayed in the GUI. The GUI may be dynamically updated in real time as new impedance values are acquired and / or analyzed, for example, as described with reference to 220.

Optionally, the body composition of each body segment is displayed corresponding to a body map showing the location of each body segment (eg, in the GUI).

Alternatively or additionally, body composition estimates for each segment are displayed, for example, as optional color-coded instructions along a range of different body compositions (eg, within the GUI). For example, other colors such as blue for body segments with high water levels and red for dehydrated body segments.

Optionally, a 3D map is calculated and displayed optionally using impedance measurements obtained at multiple different frequencies for each body segment. The 3D map may be displayed using linear gradient measurements based on different frequencies.

Optionally, the trend line is calculated and displayed in the GUI. The target body composition may be displayed with respect to the trend line. The visual display can help the user visualize when the body composition is predicted to reach the goal according to the trend line.

Reference is now made to FIG. 16, which is a schematic diagram depicting an exemplary display 1602-1604 based on analyzed impedance measurements of body segments according to some embodiments of the invention. The display 1602-1604 may be displayed in the GUI on the display of the client terminal, for example, as described herein.

Display 1602 is a graph calculated based on the Cole-Cole complex plane approach in which the measured impedance is mapped onto the RX complex plane. In the example where the display 1602 is displayed, the impedance of 50 kHz, which can be considered a key parameter, is mapped and the trend extrapolation 1606 is calculated and displayed. A portion of the RX plane corresponding to a clinically significant condition (eg, a pathological condition) may be defined. For example, region 1608 located in the upper right section of the RX plane indicates dehydration. For example, if the impedance measurement is located within the dehydration region 1608, and / or if the trend indicates that the patient has not yet dehydrated but is expected to dehydrate in the future, the patient will be dehydrated. Warning 1610 may be displayed to indicate that it is. An index of phase angle 1612 may be calculated and displayed. Phase angle and / or amplitude can be important clinical factors, for example Piccoli considers normal parameter values to be within the ellipse and deviations from the ellipse are pathological. It suggests that it will be done.

Display 1604 refers to several clinical settings for different body segments (row 1616) such as arms (eg, left and / or right), torso, legs (eg, left and / or right), and whole (ie, whole body). It is a table which summarizes the value of a parameter (column 1614). Each cell in the table (eg, 1618) displays the corresponding clinical parameter display for the corresponding body segment, eg, as dots in a bar-shaped range. Other instructions, such as numbers, color coding, and categorical indicators, may be used. One or more important parameters, such as parameters selected by the user, parameters predefined as important, and / or parameters that are abnormal clinically important values, are displayed in Box 1620. May be good.

Here, reference is made to FIG. 17, which is a schematic representation of an exemplary representation of impedance data for a plurality of body segments according to some embodiments of the invention. The display may be displayed on the display as a GUI, as described herein. The display may include a body map 1702, such as a schematic / image of the patient's body. The monitored body segment may be displayed with respect to body map 1702, eg, marked on body map 1702 and / or as an overlay on body map 1702, eg, zigzag line 1706. May be good. As shown, eight body segments are monitored and are designated Z1, Z2, Z3, Z4, Z5, Z6, Z7, and Z8. The location of the contact components (including electrodes) is marked with respect to the body map 1702, eg, on the body map 1702, and / or displayed as an overlay on the body map 1702, eg, as a dark box 1704. May be good. Body segments right wrist-right shoulder Z1, right shoulder-right buttock Z2, right buttock-right ankle Z3, left ankle-left buttock Z4, left buttock-left shoulder Z5, left shoulder-left wrist Z6, left shoulder-right buttock Z7, The right shoulder-left buttock Z8 has eight contact configurations (eg, left wrist, right wrist, left shoulder, right shoulder, left buttock, right buttock, left ankle, right ankle, or placed in close proximity to these positions). It may be monitored using the element. Instructions for the amount of one or more monitored clinical parameters (calculated based on analysis of impedance values as described herein) are given, for example, to one or more body segments. , For each segment, for a segment selected by the user, and / or for a segment with an outlier value. The indication may be displayed, for example, as an arrow on the range, color-coded at will, indicating normal and outliers. For example, as illustrated, the result icon 1708A (eg, the arrow pointing to the green zone of the value bar) indicates the normal value of the liquid in body segment Z1 and the result icon 1708B (eg, the green zone of the value bar). The pointing arrow) indicates the normal value of the liquid in the body segment Z6, the result icon 1708C (eg, the arrow pointing to the blue zone in the value bar) indicates that the body segment Z3 has a high water accumulation, and the result icon 1708D. (For example, the arrow pointing to the red zone of the value bar) indicates the dehydration state of the body segment Z4.

At 218, depending on the data displayed, eg, depending on the estimated body composition, the patient is diagnosed and / or the patient is treated and / or treatment is planned, eg, a drug is prescribed. The fluid may be administered, imaging (eg, chest X-ray, CT, MRI, such as when lung fluid is detected) may be performed, a catheter may be inserted, and the tube may be inserted. It may be removed, surgical procedures may be performed, and / or nothing is done at this time.

Diagnosis and / or treatment and / or treatment recommendations may be determined manually and / or automatically by code by a machine learning model trained, for example, on impedance values and corresponding actions taken by a professional physician. May be determined.

Analysis and / or diagnostic and / or treatment recommendations may be performed remotely, depending on impedance data collected locally, for example by code residing in the cloud and / or server. Centralized processing of data allows the use of data collected from different patients in different medical settings, resulting in data diversity (eg, different patient vitals, different clinical protocols adhered to, different levels of physicians). Training, different available treatments) can be enhanced.

At 220, one or more functions described with reference to 206-218 are repeated, for example, for dynamic updates, warnings, predictions, and / or diagnostic instructions in the GUI.

The description of the various embodiments of the invention is presented for illustration purposes, but is not intended to be exhaustive or limited to the disclosed embodiments. Many modifications and variations will be apparent to those of skill in the art without departing from the scope and gist of the embodiments described. The terminology used herein best describes the principles of the embodiment, the practical application or technical improvement to the technology found on the market, or one of ordinary skill in the art can understand the embodiments disclosed herein. It was selected as.

It is expected that many related electrodes will be developed during the term of the patent starting from the filing of the present application, and the term electrode is intended to include all such new technologies a priori. There is.

As used herein, the term "about" means ± 10%.

"Prepare", "prepare", "include", "include", "have", and their inflected forms mean "include but not limited to". The term includes the terms "consisting of" and "substantially composed of".

The expression "substantially composed of" may include additional ingredients and / or steps in the composition or method, but the additional ingredients and / or steps are claimed in the composition or. It means that it is limited to the case where the basic and new characteristics of the method are not substantially changed.

As used herein, the singular forms "a", "an" and "the" include multiple references unless the context clearly states otherwise. For example, the term "compound" or "at least one compound" may include multiple compounds, including mixtures thereof.

As used herein, the term "exemplary" is used to mean "useful as an example, case, or explanation." Any embodiment described as "exemplary" is not necessarily construed as preferred or advantageous over other embodiments, nor may it exclude the incorporation of features from other embodiments. do not have.

As used herein, the term "optionally" is used to mean "provided in one embodiment and not in another". Any particular embodiment of the invention may include multiple "arbitrary" features as long as such features do not conflict.

Throughout this application, various embodiments of the present invention may be presented in a range format. It should be understood that the description in range form is for convenience and brevity only and should not be construed as limiting the scope of the invention inflexibly. Therefore, the description of a range should be considered to specifically disclose all possible subranges, not just the individual numbers within that range. For example, the description in the range of "1-6" is "1-3", "1-4", "1-5", "2-4", "2-6", "3-6", etc. It should be considered that the subrange and the individual numbers within that range, such as "1", "2", "3", "4", "5", "6", etc., are specifically disclosed. This applies regardless of the size of the range.

When a numerical range is indicated herein, it is meant to include any cited number (decimal or integer) within the indicated range. The expressions "extending / extending" between the first instruction number and the second instruction number, and "extending / extending" from the first instruction number "to" to the second instruction number "to" , Used interchangeably herein, to include first and second instruction numbers, and all decimal and integer numbers in between.

It should be appreciated that certain features of the invention, described in the context of separate embodiments for clarity, can also be provided in combination in a single embodiment. Conversely, for brevity, the various features of the invention described in the context of a single embodiment have also been described separately, in any suitable partial combination, or elsewhere in the invention. It may be appropriately provided in the embodiment. The particular features described in the context of the various embodiments are not considered essential features of those embodiments unless the embodiments do not work without them.

Although the present invention has been described in the context of its specific embodiments, it will be apparent to those skilled in the art that many alternatives, modifications, and variations will be apparent. Therefore, it is intended to include all such alternatives, modifications, and variations that fall within the gist and broad scope of the appended claims.

All publications, patents and patent applications referred to herein may be specifically and individually indicated that the individual publications, patents or patent applications are incorporated herein by reference. To the same extent, the whole is incorporated herein by reference. In addition, the citation or specification of the prior art document in the present specification shall not be construed as admitting that the document can be used as the prior art of the present invention. As long as section headings are used, they should not necessarily be construed as limiting. Also, the priority documents of this application are incorporated herein by reference in their entirety.

Claims (34)

A system for measuring body composition in at least one body segment of a patient.
Each is a plurality of contact components including a plurality of electrodes for contacting the patient's body, each contact component is associated with a unique address, and the plurality of contact components are the same. With multiple contact components that can be independently spaced apart from different locations on the patient's body,
With at least one multimedia bus bar, each of which is connected to the electrodes of at least two of the contact components.
Using each unique address, a first set of contact components connected by a common multimedia bus bar is selected and a first body segment located between the first sets of said contact components. With a controller, which obtains at least one impedance measurement indicating the impedance of the first body segment and provides the at least one impedance measurement for estimating the body composition of the first body segment.
The system. The system of claim 1, wherein the addressing instruction output by the controller defines the operation of the corresponding electrode as a current carrier or voltage sensor and / or assigns the operation type of the component. The system of claim 1, wherein the estimation of body composition comprises an estimation of muscle mass. Each contact component of the plurality of contact components comprises three electrodes arranged along the major axis of each of the contact components, wherein the controller is a member of each of the first set of contact components. The system of claim 1, wherein the intermediate electrodes are operated for current transmission and the inner facing electrodes of each of the first set of contact components are operated for voltage measurement. The system of claim 1, wherein the plurality of contact components and the multimedia bus bar are integrated into a single flexible strip in which the address incorporates the assignment. The system of claim 1, wherein a single main multimedia bus bar connects between the controller and each one of the plurality of contact components. Each of the plurality of electrodes is associated with a respective electrode component having a unique address, and the controller may address each electrode component to each of the different contact components. The system of claim 1, wherein a set of electrodes is selected. At least some electrodes are attached to a sleeve designed to be worn on a part of the body, said sleeve having a double wall with a lumen designed to inflate, said. The sleeve is connected to the controller via a multimedia bus bar, and when used, the sleeve inflates to induce substantially equal contact pressure between the electrode and the part of the body. The system according to claim 1, wherein a 3D map is formed by collecting data from a plurality of detection strips and / or sensors embedded in a sleeve mounted on the part of the body. The system of claim 1, wherein the multi-electrode strip is attached to a portion of the body by an adhesive to provide an output for 3D impedance mapping and / or modeling indicating the muscle mass of said portion of the body. The controller repeatedly selects a second set of contact components from the plurality of contact components connected by a common multimedia bus bar, and impedances are used using the second set of electrodes of the contact components. By measuring at least one impedance measurement, the at least one impedance measurement indicates the impedance of a second body segment located between the second set of contact components, said. The system of claim 1, wherein at least one impedance measurement is provided for estimating body composition, including muscle mass and / or fat-free mass of said second body segment. At least one contact component of the first set of the contact components is disposed between the second set of the contact components, the first set of the contact components and the second set of the contact components. 10. The system of claim 10, wherein the pair is connected to the common multimedia bus bar. Each of the at least one contact component of the first set of the contact components is placed between the second set of the contact components and between the second sets of the contact components. 11. The system of claim 11, wherein the corresponding electrode is not selected and does not operate during the at least one impedance measurement performed on the body segment. 10. The system of claim 10, wherein one of the second set of contact components is selected from the first set of contact components. Further comprising a plurality of biosensors, each associated with a unique address, said plurality of biosensors are connected to at least one multimedia bus bar connected to a plurality of electrodes and said controller is said to be said at least one multi. The system according to claim 1, wherein the plurality of biosensors and the plurality of electrodes are operated by transmitting a specific unique address on a conductor bus bar. 15. The system of claim 14, wherein the plurality of biosensors is selected from the group consisting of pressure sensors, temperature sensors, pulse sensors, sound sensors, and skin conductance sensors. Each contact component of the first set and the second set of the contact components includes three electrodes arranged along a long axis, and the controller is a first set and a first set of the contact components. The intermediate electrodes of each of the two sets of contact components are used to inject and receive current, and the controller uses the first and second sets of inner facing electrodes of the contact components to apply voltage. The system according to claim 10, wherein the measurement is performed. It further comprises an internal tube for insertion into the lumen of the patient's body, each of which is at least one contact component comprising a plurality of electrodes for contacting the inner surface of the patient's body. , Each coupled to at least one contact component associated with a unique address, with at least one multimedia bus bar located outside the patient's body with the at least one contact component of the body tube. Connected to at least one contact component, the first set of contact components comprises the at least one contact component of the body tube and one contact component located outside the patient's body. The system of claim 1, wherein at least some of the electrodes are individually and directly connected directly to the controller without going through an addressing scheme. 17. The system of claim 17, wherein the body tube is selected from the group consisting of an endotracheal tube (ETT), a feeding tube, and a nasogastric tube (NG). 17. The system of claim 17, wherein at least one impedance measurement performed by the first set of electrodes of the contact component indicates the body composition of at least one lung. The controller iteratively switches between a first set and a second set of the contact components to monitor the first plurality of impedance measurements over a time interval with respect to the first body segment. 10. The system of claim 10, wherein a second plurality of impedance measurements are monitored over a time interval with respect to the second body segment. Code for displaying and dynamically updating the body composition of the first and second body segments within a graphical user interface (GUI) based on real-time first and second plurality of impedance measurements. 20. The system of claim 20, further comprising a processor to perform. The processor comprises body composition including fat-free mass (FFM), muscle mass and / or hydration status of the first and second body segments corresponding to body maps showing the location of the first and second body segments. 21. The system of claim 21, which executes the code for displaying. 21. The system of claim 21, wherein the GUI displays the body composition of the first and second body segments as an index along a range of different body compositions. Analyzing the first and second plurality of impedance measurements to predict when body composition, such as in at least one 14 of the first and second body segments, will reach clinically significant goals. 20. The system of claim 20, further comprising generating a warning indicating a prediction. Further equipped and analyzed with code that is stored in memory and can be executed to form a complex correlation analysis via an artificial intelligence (AI) model that combines the loss of muscle mass and food intake obtained from sensors in body parts. The system of claim 1, wherein the result is used to optimally manage a patient's feeding pump / nutritional components to maintain or restore muscle mass and / or the desired hydration status. 24. The system of claim 24, wherein the clinically important goal is selected from the group consisting of dehydration, hypervolemia, and FFM. The system of claim 1, wherein the body composition is selected from the group consisting of fat content, edema, water content, electrolyte content, and pathological condition. For each one of the first and second sets of contact components, the controller measures impedances at a plurality of different frequencies and by the sensors according to the plurality of different frequencies and claim 8. 20. The system of claim 20, further comprising a processor that executes code for generating and displaying 3D maps of said first and second body segments using linear gradient measurements based on the collected data. .. Body composition estimates include changes in muscle mass across body segments in multiple body segments, and the controller controls the changes in muscle mass and the amount of lipids, carbohydrates, proteins, and / or fats to administer to the patient. Based on the correlation data set correlated with, the amount of fat, carbohydrate, protein, and / or fat for each body segment is calculated, and the amount of fat, carbohydrate, protein, and / or for each of multiple body segments is calculated. The system of claim 1, wherein according to the sum of the amount of fat, an instruction is generated to be performed by a feeding pump that feeds the patient. A method of measuring body composition in at least one body segment of a patient.
The first set of contact components of a plurality of contact components connected by a common multimedia bus bar can be elected by sending an instruction indicating a unique address and on the common multimedia bus bar. Assigning as a first set of current and / or detection elements for the corresponding contact component, each contact component comprises a plurality of electrodes for contacting the patient's body, and each contact component is , Associated with each unique address, and the plurality of contact components can be placed independently at different locations on the patient's body at intervals.
Using the first set of electrodes of the contact component to obtain at least one impedance measurement, the at least one impedance measurement is between the first set of contact components. To show and obtain the impedance of the first body segment in which it is located,
To provide the at least one impedance measurement to estimate the body composition of the first body segment.
How to prepare. It further comprises obtaining an output from at least one other biosensor connected to the connected multimedia bus bar and displaying the impedance measurement in combination with said output of said at least one other biosensor. 30. The method of claim 30. 30. The method of claim 30, wherein the data collected as in claims 30 and / or 31 allows for 3D modeling of the body part being examined. 30. The method of claim 30, further comprising providing a GUI incorporating the patient's condition information, including said estimation of body composition. 30. The method of claim 30, wherein the estimation of body composition comprises muscle mass and / or hydration status.

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